The National ICD Registry Report released a new version that expands on the 2009 Annual Report to include data on leads and pediatric implants to reflect recent advancements in healthcare.

An FDA analysis using its Mini-Sentinel program puts the anticoagulant dabigatran once again on equal footing with warfarin for bleeding risks. The report, published online March 14 as a perspectives article in the New England Journal of Medicine, attributes the high number of postmarket cases of bleeding to “stimulated reporting.” 

The FDA issued a warning that azithromycin (Zithromax, Pfizer) can cause potentially fatal arrhythmias.

SAN FRANCISCO—ORBIT-AF is a prospective, longitudinal, observational study that evaluated treatment patterns and the subsequent outcomes of 10,000 patients in the U.S. As part of the analysis, Jonathan P. Piccini, MD, and his colleagues looked at potential gender disparities in the treatment and clinical outcomes of these patients. The results were presented at the American College of Cardiology (ACC) scientific session.

SAN FRANCISCO—Former American Heart Association (AHA) President Gorden F. Tomaselli, MD, sat down with the media to discuss the confounding results from the PREVAIL trial, and how the Watchman device could be applicable in clinical practice, if FDA approved.

SAN FRANCISCO—Digoxin was independently associated with a more than twofold higher rate of death, based on the large, contemporary cohort study, ATRIA-CVRN, of adults with newly diagnosed  atrial fibrillation (AF) and no history of heart failure, presented March 9 at the American College of Cardiology (ACC) scientific session. Given other available options for heart rate control, the researchers said that the role of digoxin in the management of atrial fibrillation “should be reconsidered.”

SAN FRANCISCO—After one week of flip-flopping on whether or not to release the complete results of the PREVAIL trial—that evaluates the Watchman device compared with warfarin for stroke prevention— the trial’s sponsor Boston Scientific “broke its own embargo,” according to American College of Cardiology’s (ACC) Director of Media Relations’ Beth Casteel, and the ACC decided to pull the trial as a late-breaker approximately one hour before it was set to be presented.

Boston Scientific flip-flopped on its decision to present partial results March 9 at the late-breaking clinical trials program of the American College of Cardiology (ACC) scientific sessions in San Francisco. The trial sponsor announced March 6 that it would include all three co-primary endpoints in PREVAIL.